Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses (HSIGI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03667950
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : September 19, 2018
Information provided by (Responsible Party):
University of Leipzig

Brief Summary:
In this study, gastrointestinal anastomoses are examined with a hyperspectral camera.

Condition or disease Intervention/treatment Phase
Surgical Anastomosis Procedure: Hyperspectral Imaging Not Applicable

Detailed Description:
The anastomoses were examined under standardized conditions directly after creation. The measurements were performed like described before, using the TIVITA Tissue system (Diaspective Vision GmbH, Am Salzhaff, Germany). This HSI-camera provides hyperspectral images with a high spectral resolution (5 nm) in the visible and near infrared range (500-1000 nm). The distance between camera and object was 30 cm for all measurements. The Number of Effective Pixels at this distance is 640 × 480 (x-, y-axis. The resulting field of view (FOV) has the dimensions 6.4 × 4.8 cm2 and a spatial resolution of 0.1 mm/pixel. The FOV is illuminated by 8 halogen spots (20 W each). The ceiling lights and other light sources were switched off, to avoid artifacts during the measurement (approximately 10 seconds). A RGB image and 4 false color images that represent physiologic parameters are intraoperatively provided by an analysis software. This work is focused on tissue oxygenation (StO2), which represents the relative blood oxygenation in the microcirculation of superficial tissue layers (approximately 1 mm) and the near-infrared (NIR) Perfusion Index, representing tissue layers in 4-6 mm penetration depth.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Vascular Border Zone Definition Using Intraoperative Hyperspectral Imaging for Resections and Reconstructions in Diseases of the Esophagus, Stomach, Pancreas, Small Intestine, Large Intestine and Rectum to Optimize Anastomotic Healing
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: hyperspectral imaging
diagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures
Procedure: Hyperspectral Imaging
Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.

Primary Outcome Measures :
  1. Anastomotic Perfusion: (Oxygenation (StO2) [ Time Frame: direct during the Operation (ca. 15-20 Minutes) ]
    Oxygenation (StO2) in %: Relative O2 saturation of the blood immicrocircular system in superficial tissue layers (penetration depth: approx. 1 mm)

  2. Anastomotic Perfusion: Tissue-Hemoglobin index [ Time Frame: direct during the Operation (ca. 15-20 Minutes) ]
    Tissue Hemoglobin index in %: Existing hemoglobin distribution in the microcircular system of the tissue area under consideration (index value)

  3. Anastomotic Perfusion: Near Infrared Perfusion Index [ Time Frame: direct during the Operation (ca. 15-20 Minutes) ]
    Near Infrared Perfusion Index in %: Relative O2 saturation of the blood immicrocircular system in deeper tissue layers (penetration depth: 4-6mm; index value)

  4. Anastomotic Perfusion: Tissue-Water-Index [ Time Frame: direct during the Operation (ca. 15-20 Minutes) ]
    Tissue-Water-Index in %: Existing water distribution in the tissue area under consideration (index value)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • all gastrointestinal anastomoses

Exclusion Criteria:

  • inability to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03667950

Contact: Boris Jansen-Winkeln, Dr. +49-314-97 ext 17200
Contact: Ines Gockel, Prof. Dr.

Universitätsklinikum Leipzig - AöR Recruiting
Leipzig, Sachsen, Germany, 04103
Sponsors and Collaborators
University of Leipzig
Principal Investigator: Boris Jansen-Winkeln, Dr. University of Leipzig

Responsible Party: University of Leipzig Identifier: NCT03667950     History of Changes
Other Study ID Numbers: HSIGI
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no sharing

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Leipzig:
anastomotic perfusion, tissue oxygen saturation